- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00596037
Treatment of Adults With Growth Hormone Deficiency
October 4, 2012 updated by: LG Life Sciences
A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency
The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005.
In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated.
Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study
- If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential
- Written informed consent of the patient
Exclusion Criteria:
- Evidence of active malignancy or growth of a previously stable tumor
- Benign intracranial hypertension
- Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease
- Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study
- Patients who are not able to comply with the study protocol for any reason
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LB03002 throughout
administered LB03002 for preceding 26 weeks
|
|
Experimental: Switched to LB03002
administered placebo for preceding 26 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: HJ Ji, PhD, LG Life Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
January 7, 2008
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 16, 2008
Study Record Updates
Last Update Posted (Estimate)
October 5, 2012
Last Update Submitted That Met QC Criteria
October 4, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Dwarfism
- Bone Diseases, Developmental
- Hypopituitarism
- Pituitary Diseases
- Dwarfism, Pituitary
- Endocrine System Diseases
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
Other Study ID Numbers
- BPLG-005-RO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Growth Hormone Deficiency
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyFrance
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyDenmark
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyGermany
-
Altus PharmaceuticalsCompleted
-
OPKO Health, Inc.CompletedAdult Growth Hormone DeficiencyCzechia, Hungary, Israel, Serbia, Slovakia, Slovenia
-
Novo Nordisk A/SCompletedHealthy | Growth Hormone Disorder | Adult Growth Hormone DeficiencyUnited States
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyGermany
-
AEterna ZentarisCompletedDiagnosis of Adult Growth Hormone Deficiency (AGDH)United States
-
Merck KGaA, Darmstadt, GermanyCompletedAdult Growth Hormone Deficiency
-
University Hospital BirminghamRecruitingAdult Growth Hormone DeficiencyUnited Kingdom
Clinical Trials on Growth hormone - LB03002
-
The University of Texas Medical Branch, GalvestonCompletedMild Cognitive ImpairmentUnited States
-
University of PennsylvaniaNational Institute on Aging (NIA)TerminatedAging | Hormone DeficiencyUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of WashingtonNational Institute on Aging (NIA)CompletedAging | Mild Cognitive ImpairmentUnited States
-
Massachusetts General HospitalCompleted
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHealthy VolunteersUnited States
-
University of PennsylvaniaCompletedCongestive Heart FailureUnited States
-
Versartis Inc.Completed
-
Rabin Medical CenterPfizerCompleted
-
Massachusetts General HospitalActive, not recruitingObesity | Fatty Liver | Liver Fat | Obesity, Abdominal | Non-Alcoholic Fatty Liver DiseaseUnited States